RAYSEARCH LABORATORIES AB recalls RayStation 8B Service Pack 2, UDI # 07350002010235 - Produc
Recalled Product
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Hazard / Issue
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Issued by
FDA
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